Pancreatic CancerPhase 1NCT00379639

A Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors

A Phase 1 study testing Romidepsin and Gemcitabine in people with Pancreatic Cancer, run by Celgene at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This was a phase I dose escalation trial designed to determine the maximum tolerated dose (MTD) for the combination of romidepsin (depsipeptide) and gemcitabine. The study was originally planned as a Phase I/II; however only Phase I of the study was conducted. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Cancer
What is being tested?: Romidepsin and Gemcitabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2006to 1 Jul 2008
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

histologically confirmed advanced solid tumors
measurable or evaluable disease
written informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Who cannot join

Prior treatment with romidepsin or gemcitabine
Prior chemotherapy treatment within 3 weeks prior to the first day of treatment or prior treatment with an investigational agent within 4 weeks prior to the first day of treatment. Patients must have recovered from all therapy-related toxicities (Common Terminology Criteria grade ≤ 1)
Prior radiotherapy within 4 weeks prior to the first day of treatment. Patients who have not fully recovered or whose acute toxicity related to prior radiotherapy has not returned to baseline are ineligible.
Prior surgery within 3 weeks prior to the first day of treatment, excluding surgical biopsies and port placements
Concomitant use of any other anti-cancer therapy
Concomitant use of any investigational agent

Show all 22Show fewer

Use of any investigational agent within 4 weeks of study entry
Any known cardiac abnormalities, including congenital long QT syndrome, QTcF interval >480 milliseconds, myocardial infarction within 12 months of study entry, coronary artery disease (CAD), congestive heart failure (CHF), evidence of cardiac ischemia at screening, known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest, hypertrophic cardiomegaly or restrictive cardiomyopathy chronic hypertension, any cardiac arrhythmia requiring anti-arrhythmic medication
Serum potassium <3.8 mmol/L or serum magnesium <2.0 mg/dL (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria)
Concomitant use of drugs that may cause a prolongation of the QTc
Concomitant use of CYP3A4 inhibitors
Clinically significant active infection
Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
Inadequate bone marrow or other organ function as evidenced by:
Hemoglobin <9 g/dL (Transfusions and/or erythropoietin are permitted.)
Absolute neutrophil count (ANC) ≤1.5 x 10^9 cells/L
Platelet count <100 x 10^9 cells/L or platelet count <75 x 10^9 cells/L if bone marrow disease involvement is documented
Total bilirubin >2.0 x upper limit of normal (ULN)
Aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.0 x ULN or >3.0 x ULN in the presence of demonstrable liver metastases
Serum creatinine >2.0 x ULN
Patients who are pregnant or breast-feeding
Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

Sarah Cannon Research Institute
Nashville, Tennessee, 37203

Other trials in United States

About this study

Official title: A Phase I/II Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors.

Conditions: Pancreatic Cancer
Being tested: Romidepsin, Gemcitabine
Keywords: Pancreatic cancer, advanced solid tumors
Medical subject headings: Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RomidepsinDrug
Also called ISTODAX®, Depsipeptide, FK228
7, 10 or 12 mg/m^2 via intravenous infusion over 4 hours on either Days 1, 8 and 15 or Days 1 and 15 of each 28-day cycle.
GemcitabineDrug
Also called Gemzar®
800 or 1000 mg/m^2 via intravenous infusion over 30 minutes on either Days 1,8 and 15 or Days 1 and 15 of each 28 day cycle.

Study groups in NCT00379639
Study group	Role	What they receive
Romidepsin / Gemcitabine	Experimental	Participants were to receive 7, 10 or 12 mg/m^2 of romidepsin intravenously on either Days 1, 8 and 15 (Schedule A) or Days 1 and 15 (Schedule B) of each 28-day cycle, followed by 800 or 1000 mg/m^2 of gemcitabine. Subsequent doses of both drugs were based on treatment-related toxicities. The planned duration of study therapy was 6 cycles or until disease progression occurred. Patients who responded could continue beyond 6 cycles until disease progression or until a withdrawal criterion was met. Receives: Drug: Romidepsin; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With a Dose-limiting Toxicity (DLT)
Toxicities were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), V 3.0. A DLT was one of the following, if considered at least possibly related to study treatment:
Grade 4 neutropenia for ≥5 days or febrile neutropenia; Grade 4 thrombocytopenia or need for a platelet transfusion; ≥ Grade 3 nausea and/or emesis despite using optimal antiemetic therapy; ≥ Grade 3 diarrhea despite using maximal supportive therapy; Any clinically significant Grade 3 or 4 nonhematologic toxicity; Inability to administer all doses in cycle 1.
Measured: 28 days
Number of Participants With Adverse Events (AEs)
AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.
A serious AE is associated with events that pose a threat to a patient's life or functioning, require hospitalization, is a congenital anomaly/birth defect or is an important medical event or condition that may jeopardize the patient and may require medical or surgical intervention to prevent one of the above outcomes.
Measured: From the date of first dose to 30 days after last dose (up to 236 days).
Best Overall Response
Disease response was determined by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria using computed tomography or magnetic resonance imaging:
Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of ≥1 new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Measured: Disease assessments were performed within 4 weeks of first dose and every 8 weeks thereafter (up to 236 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20061 Jul 2008

First posted22 Sep 2006 (estimated)
Study start1 Jul 2006
Primary completion1 Jul 2008
Study completion1 Jul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pancreatic CancerStudies of the same condition, open and under way.
More trials run by CelgeneThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00379639
Sponsor's protocol ID: GPI-06-0003
Status last verified: Oct 2019
First submitted: 20 Sep 2006
Last updated: 30 Oct 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Jones SF, Infante JR, Spigel DR, Peacock NW, Thompson DS, Greco FA, McCulloch W, Burris HA 3rd. Phase 1 results from a study of romidepsin in combination with gemcitabine in patients with advanced solid tumors. Cancer Invest. 2012 Jul;30(6):481-6. doi: 10.3109/07357907.2012.675382. Epub 2012 Apr 26.
PubMed 22536933

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors.
ClinicalTrials.gov ID: NCT00379639
Acronym / sponsor ID: GPI-06-0003
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer, advanced solid tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: CelgeneIndustry (pharma, biotech, devices)
Study start: 1 Jul 2006 (actual)
Primary completion: 1 Jul 2008 (actual)
Study completion: 1 Jul 2008 (actual)
First posted: 22 Sep 2006 (estimated)
Results: Posted 13 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Romidepsin / Gemcitabine	Experimental	Drug: Romidepsin, Drug: GemcitabineParticipants were to receive 7, 10 or 12 mg/m^2 of romidepsin intravenously on either Days 1, 8 and 15 (Schedule A) or Days 1 and 15 (Schedule B) of each 28-day cycle, followed by 800 or 1000 mg/m^2 of gemcitabine. Subsequent doses of both drugs were based on treatment-related toxicities. The planned duration of study therapy was 6 cycles or until disease progression occurred. Patients who responded could continue beyond 6 cycles until disease progression or until a withdrawal criterion was met.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

histologically confirmed advanced solid tumors
measurable or evaluable disease
written informed consent
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Key exclusion criteria (22 listed)

Prior treatment with romidepsin or gemcitabine
Prior chemotherapy treatment within 3 weeks prior to the first day of treatment or prior treatment with an investigational agent within 4 weeks prior to the first day of treatment. Patients must have recovered from all therapy-related toxicities (Common Terminology Criteria grade ≤ 1)
Prior radiotherapy within 4 weeks prior to the first day of treatment. Patients who have not fully recovered or whose acute toxicity related to prior radiotherapy has not returned to baseline are ineligible.
Prior surgery within 3 weeks prior to the first day of treatment, excluding surgical biopsies and port placements
Concomitant use of any other anti-cancer therapy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RomidepsinAlso: ISTODAX®, Depsipeptide, FK2287, 10 or 12 mg/m^2 via intravenous infusion over 4 hours on either Days 1, 8 and 15 or Days 1 and 15 of each 28-day cycle.	Drug	Romidepsin / Gemcitabine
GemcitabineAlso: Gemzar®800 or 1000 mg/m^2 via intravenous infusion over 30 minutes on either Days 1,8 and 15 or Days 1 and 15 of each 28 day cycle.	Drug	Romidepsin / Gemcitabine

Primary outcome

Number of Participants With a Dose-limiting Toxicity (DLT)
Time frame: 28 days
Toxicities were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), V 3.0. A DLT was one of the following, if considered at least possibly related to study treatment: Grade 4 neutropenia for ≥5 days or febrile neutropenia; Grade 4 thrombocytopenia or need for a platelet transfusion; ≥ Grade 3 nausea and/or emesis despite using optimal antiemetic therapy; ≥ Grade 3 diarrhea despite using maximal supportive therapy; Any clinically significant Grade 3 or 4 nonhematologic toxicity; Inability to administer all doses in cycle 1.
Number of Participants With Adverse Events (AEs)
Time frame: From the date of first dose to 30 days after last dose (up to 236 days).
AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death. A serious AE is associated with events that pose a threat to a patient's life or functioning, require hospitalization, is a congenital anomaly/birth defect or is an important medical event or condition that may jeopardize the patient and may require medical or surgical intervention to prevent one of the above outcomes.
Best Overall Response
Time frame: Disease assessments were performed within 4 weeks of first dose and every 8 weeks thereafter (up to 236 days).
Disease response was determined by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria using computed tomography or magnetic resonance imaging: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions or the appearance of ≥1 new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Results and safety

Results posted to the registry on 13 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Level 1	7	4
Dose Level 2	7	2
Dose Level 5	10	1
Dose Level 6	6	0
Dose Level 8	6	0

Primary outcome: Number of Participants With a Dose-limiting Toxicity (DLT)

Time frame: 28 days. Number. Unit: participants

Measure	Dose Level 1 n = 7	Dose Level 2 n = 7	Dose Level 5 n = 10	Dose Level 6 n = 6	Dose Level 8 n = 6
Value	3	1	0	2	0

Population analysed: Safety population - all participants who received at least one dose of study drug.

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: From the date of first dose to 30 days after last dose (up to 236 days).. Number. Unit: participants

Measure	Dose Level 1 n = 7	Dose Level 2 n = 7	Dose Level 5 n = 10	Dose Level 6 n = 6	Dose Level 8 n = 6
Any adverse event	7	7	10	6	6
≥Grade 3 adverse event	7	5	5	4	3
Grade 4 adverse event	1	2	3	2	1
Serious adverse event	3	2	4	1	2
Adverse event leading to discontinuation	0	0	1	0	1
Adverse event leading to death	0	0	0	0	1

Population analysed: Safety population.

Primary outcome: Best Overall Response

Time frame: Disease assessments were performed within 4 weeks of first dose and every 8 weeks thereafter (up to 236 days).. Number. Unit: participants

Measure	Dose Level 1 n = 6	Dose Level 2 n = 7	Dose Level 5 n = 7	Dose Level 6 n = 4	Dose Level 8 n = 3
Complete Response	0	0	0	0	0
Partial Response	0	1	0	0	1
Stable disease	5	4	3	1	1
Progressive disease	1	2	4	3	1

Population analysed: The Efficacy Evaluable (EE) population consisted of all patients who completed at least 2 consecutive cycles of treatment, had at least 1 post-Baseline efficacy assessment performed, and did not have any major protocol violations.

Adverse events

Time frame: From the date of first dose to 30 days after last dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose Level 1	3 of 7 (42.9%)	7 of 7 (100%)	Not reported
Dose Level 2	2 of 7 (28.6%)	7 of 7 (100%)	Not reported
Dose Level 5	4 of 10 (40%)	10 of 10 (100%)	Not reported
Dose Level 6	1 of 6 (16.7%)	6 of 6 (100%)	Not reported
Dose Level 8	2 of 6 (33.3%)	6 of 6 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22536933Jones SF, Infante JR, Spigel DR, Peacock NW, Thompson DS, Greco FA, McCulloch W, Burris HA 3rd. Phase 1 results from a study of romidepsin in combination with gemcitabine in patients with advanced solid tumors. Cancer Invest. 2012 Jul;30(6):481-6. doi: 10.3109/07357907.2012.675382. Epub 2012 Apr 26.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Howard A. Burris, M.D. principal investigator

SCRI Development Innovations, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Romidepsin and Gemcitabine in people with Pancreatic Cancer, run by Celgene at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Dose-limiting Toxicity (DLT) (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00379639, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.